XALACOM EYE DROPS
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
27-02-2023
خصائص المنتج
(SPC)
12-10-2022
تقرير التقييم الجمهور
(PAR)
18-08-2016
العنصر النشط:
LATANOPROST; TIMOLOL AS MALEATE
متاح من:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC رمز:
S01EX
الشكل الصيدلاني:
EYE DROPS, SOLUTION
تركيب:
LATANOPROST 50 MCG/ML; TIMOLOL AS MALEATE 5 MG/ML
طريقة التعاطي:
OCULAR
نوع الوصفة الطبية :
Required
المصنعة من قبل:
PFIZER INC, USA
المجموعة العلاجية:
OTHER ANTIGLAUCOMA PREPARATIONS
الخصائص العلاجية:
Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers.
تاريخ الترخيص:
2022-01-31
نشرة المعلومات
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
XALACOM
® EYE DROPS
LATANOPROST 50 MCG/ML
TIMOLOL (AS MALEATE) 5 MG/ML
Inactive
and allergenic ingredients in the preparation: see section 2
“Important
information regarding some of the ingredients of the medicine” and
section 6 “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to
the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
For reducing intraocular pressure in patients with open-angle glaucoma
and intraocular
hypertension that are not fully responsive to beta-blockers (intended
for external use).
THERAPEUTIC GROUP:
LATANOPROST –
a prostaglandin analog. It works by increasing the outflow of fluid
from
the eye into the bloodstream.
TIMOLOL –
a beta-blocker. It works by slowing the formation of fluid in the eye.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
x
You are sensitive (allergic) to the active ingredients or to any of
the other
ingredients contained in the medicine (as listed in section 6).
x You are sensitive (allergic) to preparations from the beta-blocker
group.
x You
are
suffering,
or
have
suffered
in
the
past,
from
respiratory
system
disturbances, such as: asthma, severe chronic obstructive bronchitis
(a severe lung
disease that may be manifested by wheezing, difficulty breathing
and/or a
prolonged cough).
x You are suffering from severe heart problems or from heart rhythm
disturbances.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH XALACOM, TELL THE DOCTOR IF:
• You are suffering, or have suffered in the past, from coronary
heart disease (the
symptoms can include chest pain
اقرأ الوثيقة كاملة
خصائص المنتج
Xalacom eye drops LPD WC 220922
1
2022-0077007
PS
EYE DRO
®
M
ACO
AL
X
1. NAME OF THE MEDICINAL PRODUCT
Xalacom
®
eye drops.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1mL solution contains latanoprost 50 micrograms and
timolol maleate 6.8 mg equivalent to 5 mg timolol.
Excipients with known effect: Benzalkonium chloride 0.2 mg
/ml
Disodium phosphate, sodium dihydrogen phosphate monohydrate
(containing total phosphate 6.3 mg/mL).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle
glaucoma and ocular hypertension who are
insufficiently responsive to topical beta-blockers.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_Adults (including the elderly)_
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not exceed
one drop in the effected eye(s) daily, since it has been shown that
more frequent administration of latanoprost
decreases the intraocular pressure lowering effect.
_Paediatric population_
The safety and efficacy of Xalacom eye drops in children below 18
years of age has not been established.
Method of administration
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes.
(see section 4.4)
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five minutes
apart.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic absorption is reduced.
This may result in a decrease in systemic side effects and an increase
in local activity.
Xalacom eye drops LPD WC 220922
2
2022-0077007
4.3. CONTRAINDICATIONS
Xalacom is contraindicated in patients with:
•
Reactive airway disease including bronchial asthma or a history of
bronchial asthma, severe chronic
obstructi
اقرأ الوثيقة كاملة
